Sr/Officer - Aggregate Report Writing (PSUR,) @ Lambda Therapeutic

Job Description

Roles and Responsibilities

• Preparation of full PSURs (PBRER format), PADERs, Addendum to Clinical overview summary report, and Risk Management Plan as per GVP and / ICH guidelines
• Preparation of educational materials for additional risk minimization measures and additional PV activities
• Safety data analysis from line listing generated from Pharmacovigilance database for signal and risk evaluation
• Review of published literatures for new significant safety information,
• Review of safety data reported from clinical/non-clinical studies and safety variations
• Awareness of MedDRA coding and its terminologies
• Through awareness of good pharmacovigilance guidelines for EU, Non-EU, and other and RoW countries
• To ensure pharmacovigilance activities are carried out in accordance with company SOPs and applicable regulations / guidelines
• To provide support to other members of the pharmacovigilance team as required
• To ensure the provision of appropriate pharmacovigilance advice to clients and colleagues
• Assist in the development of appropriate standard operating procedures
• Any other tasks as requested as by line manager to meet the business requirements

Desired Candidate Profile

BPharma or Mpharma with 3-4 years of experience in Aggregate report writing

Perks and Benefits

Job Classification

Education

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Rs 0 - 50K PM Rs 50K - 1 LPA Rs 1.0 - 1.5 LPA Rs 1.5 - 2.0 LPA Rs 2.0 - 2.5 LPA Rs 2.5 - 3.0 LPA Rs 3.0 - 3.5 LPA Rs 3.5 - 4.0 LPA Rs 4.0 - 4.5 LPA Rs 4.5 - 5.0 LPA Rs 5 - 6 LPA Rs 6 - 7 LPA Rs 7 - 8 LPA Rs 8 - 9 LPA Rs 9 - 10 LPA Rs 10 - 12 LPA Rs 12 - 14 LPA Rs 14 - 16 LPA Rs 16 - 18 LPA Rs 18 - 20 LPA Rs 20 - 22 LPA Rs 22 - 24 LPA Rs 24 - 26 LPA Rs 26 - 28 LPA Rs 28 - 30 LPA Rs 30 - 32 LPA Rs 32 - 34 LPA Rs 34 - 36 LPA Rs 36 - 38 LPA Rs 38 - 40 LPA Rs 40 - 42 LPA Rs 42 - 44 LPA Rs 44 - 46 LPA Rs 46 - 48 LPA Rs 48 - 50 LPA Rs 50 - 75 LPA Rs 75 Lakh - 1C PA Rs 1 Crore+ PA

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Keyskills:   aggregate report writing pharmacovigilance Medical Writing report writing